Another astronomical drug hike: Price of opioid antidote leaps 600%

Kentucky Crime Lab forensic scientist specialist II, Susan Robinson, discusses how she and colleagues are modifying their procedures as they see the powerful opioid fentanyl appear more and more frequently.
Alton Strupp/The CJ

Dr. Eric Edwards, chief medical officer and vice president of research and development for Kaléo Pharmaceuticals in Richmond, Va., demonstrates April 4, 2014, how to use Evzio, a product the company developed that reverses the effects of pain medicine or heroin overdose.(Photo: Bob Brown, AP)

DETROIT — The price for an injectable drug touted as an antidote for opioid overdoses has jumped more than 600%, prompting outrage from first responders to health advocates to the U.S. Senate.

Evzio contains naloxone, which saves the lives of people who are overdosing. The U.S. Food and Drug Administration-approved medication is designed to be used by people who don't have medical training, such as police officers and families who have relatives with substance-abuse problems.

The price for Evzio, which is an important tool to deal with the U.S. opioid crisis, jumped from $690 in 2014 to $4,500 now.

That's against the backdrop of a huge rise in the number of prescription opioid overdose deaths in the U.S.

The figure has quadrupled since 1999, according to the federal Centers for Disease Control and Prevention. During that period, more than 183,000 people died.

On Wednesday, 31 U.S. senators sent a letter to Kaléo Pharmaceuticals, the maker of Evzio, to complain.

“People are willing to pay for it because they really don’t have other alternatives.”

Pinar Karaca-Mandic, University of Minnesota

"Such a steep rise in the cost of this drug threatens to price out families and communities that depend on naloxone to save lives," the letter reads. "At a time when Congress has worked to expand access to naloxone products and to assist state and local communities to equip first responders with this lifesaving drug, this startling price hike is very concerning."

Naloxone also comes in a nasal spray and an injectable that health care professionals can use.

The uproar mirrors that surrounding the huge price increases for the EpiPen, an epinephrine auto-injector that is used on people in the midst of life-threatening allergic reactions, and the toxoplasmosis drug Daraprim, used by people who have AIDS, cancer or a weakened immune system.

People with commercial insurance can get Evzio for free whether or not they have high-deductible plans or if Evzio isn't covered by their insurance companies, as can patients without insurance who have a household income below $100,000, according to the Spencer Williamson, chief executive of the Richmond, Va.-based drugmaker Kaléo. It's $360 for patients paying cash.

Though the company is privately held, public company PDL BioPharma loaned Kaléo $150 million in April 2014 to support what the company called commercialization of the drug that the FDA approved April 3, 2014.

"In February 2016, the list price of Evzio increased so that we could launch this access program for patients," Williamson said in a written statement. "Because of this patient-access program for Evzio, more Americans are able to obtain naloxone for $0 out-of-pocket than any time in history."

The company called the prices, $690 and $4,500, incorrect.

“In February 2016, the list price of Evzio increased so that we could launch this access program for patients. Because of this patient-access program for Evzio, more Americans are able to obtain naloxone for $0 out-of-pocket than any time in history.”

Spencer Williamson, Kaléo Pharmaceuticals

But the figures the senators cited come from a study published in the New England Journal of Medicine.

The listed wholesale price, which is for distributors selling to pharmacies, is $4,100, Williamson said. But that's "not a true net price to anyone, including the distributors or pharmacies, due to numerous discounts and rebates that are negotiated in the supply chain that make up our health-care system."

He added that Kaléo has donated nearly 200,000 doses to "public health departments, first responders and nonprofits serving patients in need."

Naloxone is an important lifesaving medication for those with opioid overdoses, FDA officials said. The agency doesn't have the authority to review or approve drug prices, which manufacturers and distributors set.

"The agency recognizes that emergency treatment of known or suspected opioid overdose is an urgent public-health priority, and there is still a need to improve access to naloxone to save lives from overdoses. Identifying ways to make naloxone more accessible is an important component of the FDA’s opioid action plan," spokesman Michael Felberbaum said in an e-mail.

Evzio's cost increase is part of of a larger trend — a perfect storm of monopolies, constant demand and societal ills.

"There's a highly inelastic demand, meaning people are willing to pay for it because they really don’t have other alternatives," said Pinar Karaca-Mandic, an associate professor of health policy and management at the University of Minnesota. "There has been a big shift in demand. Naloxone used to be pretty much used by hospitals and ambulances. It didn’t have as much demand, but with the opioid epidemic, ... there’s a big market.

While it is reasonable for drug companies to want to recoup research and development costs and for society to want to reward pharmaceutical innovation, the health economist said the way to stop such price increases is to change the rules of the game.

"Policy makers' goals should be increased competition in the market, so they can’t behave like this," she said. The FDA should give "incentives to other companies to provide other generic versions of naloxone or decrease the regulatory (burden) for other companies to speed up alternatives."